CHIROCAINE Solution for injection Ref.[9273] Active ingredients: Levobupivacaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK

Product name and form

Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion.

Pharmaceutical Form

Solution for injection/concentrate for solution for infusion.

Clear colourless solution.

Qualitative and quantitative composition

One ml contains 5 mg levobupivacaine as levobupivacaine hydrochloride.

Each ampoule contains 50 mg in 10 ml.

Excipients with known effect: 3.5 mg/ml of sodium per ampoule.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levobupivacaine

Levobupivacaine is a long acting local anaesthetic and analgesic. It blocks nerve conduction in sensory and motor nerves largely by interacting with voltage sensitive sodium channels on the cell membrane, but also potassium and calcium channels are blocked. In addition, levobupivacaine interferes with impulse transmission and conduction in other tissues where effects on the cardiovascular and central nervous systems are most important for the occurrence of clinical adverse reactions.

List of Excipients

Sodium chloride
Sodium hydroxide
Hydrochloric acid
Water for injections

Pack sizes and marketing

Chirocaine is available in two presentations:

  • 10 ml polypropylene ampoule in packs of 5, 10 & 20
  • 10 ml polypropylene ampoule, in sterile blister packs of 5, 10 & 20

Not all pack sizes may be marketed.

Marketing authorization holder

AbbVie Ltd., Maidenhead, SL6 4UB, UK

Marketing authorization dates and numbers

PL41042/0006

Date of first authorisation: 06th January 2000

Date of last renewal: 18th December 2013

Drugs

Drug Countries
CHIROCAINE Finland, France, Hong Kong, Ireland, Lithuania, Turkey, United Kingdom

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